Reduction of Hypertrophic Skin ScarringPhase 2NCT01730339

Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery

A Phase 2 study testing PF-06473871 in people with Reduction of Hypertrophic Skin Scarring, run by Pfizer at 40 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study will compare how well PF-06473871 works versus placebo in reducing skin scarring after scar revision surgery of existing breast scars. The study will also evaluate the safety of PF-06473871 in healthy adult subjects. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Reduction of Hypertrophic Skin Scarring
What is being tested?: PF-06473871
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 40 sitesin 4 countries
Study dates: Dec 2012to Oct 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects must have hypertrophic (raised) breast scars from previous surgery
Subjects must be healthy

Who cannot join

Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or breast-feeding.
Presence of history of breast cancer

Trial locations and contacts

40 sites in 4 countries.

Country

City, postcode or hospital

40 sites in 4 countries

United States36 sites

Atlanta APC Plastic Surgery
Atlanta, Georgia, 30308
Kavali Plastic Surgery and Skin Renewal Center
Atlanta, Georgia, 30328
Perimeter Outpatient Surgery Center
Atlanta, Georgia, 30328
Advanced Medical Resarch ,Inc
Atlanta, Georgia, 30342
Office of Paul M. Glat ,MD
Bala-Cynwyd, Pennsylvania, 19004
Sanctuary Mediacal Center
Boca Raton, Florida, 33431
Northwestern University Diagnostic Testing Center
Chicago, Illinois, 60611
Northwestern University,Division of Plastic Surgery
Chicago, Illinois, 60611
Atlanta APC Plastic Surgery
Conyers, Georgia, 30012
Stephan Baker, MD PA
Coral Gables, Florida, 33146
Long Island Plastic Surgical Group, P.C
Garden City, New York, 11530
The Hunstad Kortesis Center for Cosmetic Surgery
Huntersville, North Carolina, 28078
University of California Irvine - Dermatology Research
Irvine, California, 92697
Spivey Station Surgery Center
Jonesboro, Georgia, 30236
Plastic Surgery and Laser Institute of San Diego
La Jolla, California, 92037
Scripps Memorial-Ximed Medical Center
La Jolla, California, 92037
Altus Research
Lake Worth, Florida, 33461
Long Island Plastic Surgical Group, P.C.
Manhasset, New York, 11030
Bayside Ambulatory Center
Miami, Florida, 33133
Laser Skin Surgery Center of NY
New York, New York, 10016
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Black Hill Surgical Hospital
Rapid City, South Dakota, 57702
Health Concepts
Rapid City, South Dakota, 57702
Body Aesthetic Research Center
St Louis, Missouri, 63141
Mercy Clinic Heart and Vascular
St Louis, Missouri, 63141
Fort Bend Imaging
Sugar Land, Texas, 77478
Luxe Plastic Surgery
Sugar Land, Texas, 77479
University of South Florida
Tampa, Florida, 33606
Connall Consmetic Surgery
Tualatin, Oregon, 97062
Meridian Center for Surgical Excellence, LLC
Tualatin, Oregon, 97062
Timothy P. Connall, MD PC
Tualatin, Oregon, 97062
Advanced Cosmetic Surgery Clinic of Walnut Creek
Walnut Creek, California, 94596
Anthony DeMeo, MD
Walnut Creek, California, 94596
Charles Hanson MD
Walnut Creek, California, 94598
PIH Health Plastic Surgery and Aesthetic Medicine
Whittier, California, 90602
PIH health
Whittier, California, 90640

Other trials in United States

Spain2 sites

Hospital Santa Creu I Sant Pau
Barcelona, Barcelona, 08025
Clinica La Luz
Madrid, Madrid, 28003

Other trials in Spain

Germany1 site

Noahklinik,Klinik Plastische, Rekonstruktive und Asthetische Chirurgie, Handchirurgie am Roten Kreuz
Kassel, Hesse, 34121

Other trials in Germany

Hungary1 site

Magyar Honvedseg-Egeszsegugyi Kozpont
Budapest, Budapest, 1134

Other trials in Hungary

About this study

Official title: A Phase 2, Randomized, Double-blind, Within-subject, Placebo Controlled Study To Evaluate The Efficacy And Safety Of Pf 06473871 In Reducing Hypertrophic Skin Scarring

Conditions: Reduction of Hypertrophic Skin Scarring
Being tested: PF-06473871
Keywords: Skin scarring, cicatrix, breast scar, hypertrophic scar
Medical subject headings: Cicatrix, Cicatrix, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-06473871Drug
Single dose administered by injection four different times
PF-06473871Drug
Single dose administered by injection three different times

Study groups in NCT01730339
Study group	Role	What they receive
Group 1	Active comparator	Not described Receives: Drug: PF-06473871
Group 2	Active comparator	Not described Receives: Drug: PF-06473871

What is being measured

The primary outcome is the main question the study is designed to answer.

Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)
Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.
Measured: Week 24

Secondary outcomes (4)

Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). Within participant treatment difference was assessed between the treatment regimens each participant received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1.
Measured: Week 8, 11, 18, 24
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)
Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference was assessed between the treatment regimens each participant received
Measured: Week 8, 11, 18, 24
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score
PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Participants completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0-100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Within participant treatment difference was assessed between the treatment regimens each participant received.
Measured: Week 8, 24
Physician and Participant Photoguide Scar Assessment Scale Score
Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within participant treatment difference was assessed between the treatment regimens each participant received.
Measured: Week 8, 11, 18, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Oct 2014

First posted21 Nov 2012 (estimated)
Study startDec 2012
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Reduction of Hypertrophic Skin ScarringStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01730339
Sponsor's protocol ID: B5301001
Other IDs: 2012-004355-37
Status last verified: Jan 2016
First submitted: 12 Nov 2012
Last updated: 17 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Within-subject, Placebo Controlled Study To Evaluate The Efficacy And Safety Of Pf 06473871 In Reducing Hypertrophic Skin Scarring
ClinicalTrials.gov ID: NCT01730339
Acronym / sponsor ID: B5301001
Conditions: Reduction of Hypertrophic Skin Scarring
Keywords: Skin scarring, cicatrix, breast scar, hypertrophic scar
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 21 Nov 2012 (estimated)
Results: Posted 20 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group 1	Active comparator	Drug: PF-06473871
Group 2	Active comparator	Drug: PF-06473871

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Subjects must have hypertrophic (raised) breast scars from previous surgery
Subjects must be healthy

Key exclusion criteria (2 listed)

Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or breast-feeding.
Presence of history of breast cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-06473871Single dose administered by injection four different times	Drug	Group 1
PF-06473871Single dose administered by injection three different times	Drug	Group 2

Primary outcome

Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Week 24
Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.

4 secondary outcomes

Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Week 8, 11, 18, 24
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Week 8, 11, 18, 24
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score
Time frame: Week 8, 24
Physician and Participant Photoguide Scar Assessment Scale Score
Time frame: Week 8, 11, 18, 24

Results and safety

Results posted to the registry on 20 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-06473871/Placebo (4* 5 mg/cm)	45	40
PF-06473871/Placebo (3* 5 mg/cm)	55	52

Primary outcome: Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)

Time frame: Week 24. Least squares mean (Standard Error). Unit: units on scale

Measure	Group 1: PF-06473871: 4* 5 mg/cm n = 43	Group 1: Placebo 4* 5 mg/cm n = 43	Group 2: PF¬06473871: 3* 5 mg/cm n = 53	Group 2: Placebo 3* 5 mg/cm n = 53
Value	4.00 (0.30)	4.68 (0.27)	4.61 (0.29)	4.86 (0.28)

Group 1: PF-06473871: 4* 5 mg/cm vs Group 1: Placebo 4* 5 mg/cm: Least Square mean difference: 0.68 (90% CI 0.19 to 1.16), p = 0.0219, Repeated measures model
Group 2: PF¬06473871: 3* 5 mg/cm vs Group 2: Placebo 3* 5 mg/cm: Least Square mean difference: 0.24 (90% CI -0.24 to 0.72), p = 0.4038, Repeated measures model

Population analysed: Modified Intent To Treat (mITT) population included all participants who were randomized and received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Week 24. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-06473871/Placebo (4* 5 mg/cm)	0 of 45 (0%)	30 of 45 (66.7%)	Not reported
PF-06473871/Placebo (3* 5 mg/cm)	0 of 55 (0%)	35 of 55 (63.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

40 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06473871 in people with Reduction of Hypertrophic Skin Scarring, run by Pfizer at 40 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Spain, Germany, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01730339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.